Recall Z-2618-2025— Boston Scientific Corporation

Name: FDA recall Z-2618-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-28

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2025-08-28. It names one FDA 510(k) clearance: K102082. Product: Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);. Reason: The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-08-28
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K102082 — EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470Boston Scientific Corp·cleared 2010-08-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

Reason for recall

The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

Data sourced from openFDA. This site is unofficial and independent of the FDA.